Sr Process Engineer 1

Overview
A Sr Process Engineer 1 provides engineering technical guidance with limited or no direction, primarily focusing on client process fit within existing facility designs and specifying equipment and facility gaps for Drug Substance (DS) and Drug Product (DP) processes. This role champions transformation of engineering, manufacturing, and facility technologies, participates in industry forums, and provides technical engineering expertise for new processing equipment designs, installations and modifications to existing equipment and facility.
External US

• Serves as a technical leader in the client facility fit assessment and process design for equipment, facility, and operational capabilities
• Manages assessments and feasibility studies for prospective new and expanded capabilities for equipment, manufacturing, etc.
• Drives engineering studies to confirm process fit to plant for new processes and changes to existing processes
• Provides equipment design expertise and advice to guide major project(s) or other activities
• Leads equipment capital expenditure estimates
• Supports development of procurement packages by partnering with Project Engineering
• Identifies gaps, provides suggestions and drives implementation of improvements within the Drug Substance (DS) and Drug Product (DP) manufacturing areas
• Partners with the Process Engineering/Science teams as a lead for identifying process optimizations and potential bottlenecks
• Interacts with senior internal and external personnel on significant matters and cross-functional coordination, as required
• Provides regular updates to senior leadership on strategic initiatives, key technical efforts, facility fits and investments
• Serves as subject matter expert (SME) for process equipment & technologies, including upstream and downstream processes
• Supports site expansion project planning and future design
• Leads transition into technology transfer (detailed mass balance, equipment flow diagrams and technical consultation)
• Provides support to Program Management, Manufacturing, Technical Operations, EH&S, etc., concerning new client processes and equipment, as needed

Minimum Requirements:

• Bachelor's degree in Engineering or a related field with 8 years of Engineering or other relevant technical work experience; or
• Master's degree in Engineering or a related field with 6 years of Engineering or other relevant technical work experience
• Experience with Drug Substance or Drug Product process equipment and unit operations is required
• Prior experience working in a cGMP environment or other highly regulated industry

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.
PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection. X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability to stand for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to sit for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. X No Yes
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments. X No Yes Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes